Micro-needle bladder balloon
Devices and methods for delivering treatment fluids or particulates such as, stem cells, drugs, Botox and like, to an inner lining of a bladder for treatment of urinary tract disorders, including over-active bladder. A balloon delivery system can include an inflation balloon having a plurality of micro-needles configured to pierce and otherwise puncture an inner bladder wall so as to deliver the treatment fluid to bladder tissue. The treatment fluid can be directly injected into the bladder tissue using the micro needles. Alternatively, the micro needles can be fabricated of bioabsorbable or bioresorbable materials such that the micro needles can remain embedded within the bladder tissue to deliver the treatment fluid or particulate.
1 . A balloon delivery system for delivering a treatment fluid to bladder tissue, comprising:
a balloon catheter including a catheter body having a distal treatment end, the distal treatment end including an inflation balloon and an internal balloon,
the internal balloon having an external surface defining a plurality of lowered portions,
the inflation balloon includes a plurality of micro needles, each micro needle including a needle tip for puncturing an inner bladder wall for delivery of a treatment medicant into bladder tissue, each micro needle being associated with at least one of the plurality of lowered portions of the external surface of the internal balloon, a first portion of the inflation balloon being disposed a first distance from the internal balloon, a second portion of the inflation balloon being disposed a second distance from one of the plurality of lowered portions of the internal balloon, the second distance being greater than the first distance.
2 . The balloon delivery system of claim 1 , wherein the plurality of micro needles are formed directly on an exterior surface of the inflation balloon.
3 . The balloon delivery system of claim 2 , wherein a treatment fluid is located between the inflation balloon and the internal balloon such that inflation of the internal balloon pressurizes the treatment fluid for injection through the plurality of micro needles.
4 . The balloon delivery system of claim 3 , wherein each micro needle is defined within a recessed area on the exterior surface, the recessed area further comprising a pair of hinges with a hinge on each side of the micro needle, wherein inflation of the internal balloon causes each recessed area to be directed outward with the pair of hinges directing each micro needle into the inner bladder wall.
5 . The balloon delivery system of claim 3 , wherein each micro needle comprises a stiff dimple formed by passing a needle through an interior surface of inflation balloon and out the exterior surface such that said stiff dimple punctures the inner bladder wall with the inflation balloon in the fully inflated disposition.
6 . The balloon delivery system of claim 2 , wherein each micro needle is fabricated of a bioabsorbable or bioresorbable polymer and wherein each micro needle comprises a plurality of barbs such that each barb becomes embedded in the inner bladder wall with the inflation balloon in a fully inflated disposition and whereupon said plurality of barbs retain each micro needle within the inner bladder wall as the inflation balloon is deflated and assumes an uninflated disposition causing each micro needle to break off of the exterior surface of the inflation balloon.
7 . The balloon delivery system of claim 6 , wherein a treatment medicant is administered into bladder tissue during a time period in which the bioabsorbable or bioresorbable polymer is broken down by the bladder tissue.
8 . The balloon delivery system of claim 7 , wherein each micro needle includes an internal reservoir for retaining the treatment medicant.
9 . The balloon delivery system of claim 7 , wherein the treatment medicant is included within the bioabsorbable or bioresorbable polymer during formation of each micro needle.